Events

Recall of Device Recall Smith and Nephew TWINFIX QUICKT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74449
  • Event Risk Class
    Class 2
  • Event Number
    Z-2218-2016
  • Event Initiated Date
    2016-06-15
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147612
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    arthroscope accessory - Product Code NBH
  • Reason
    The device could be subject to breaches of its sterile packaging.
  • Action
    Urgent Recall Notification Letters were sent via Federal Express on June 15, 2016, to the customers listed in the firm's distribution report. Customers were asked to inventory their devices and contact the firm for return authorizations.

Device

Device Recall Smith and Nephew TWINFIX QUICKT
  • Model / Serial
    Batch numbers: 50412843, 50477278, 50527184
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide, AT, AU, DE, FR, GB, JP, PT, and RU.
  • Product Description
    Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Manufacturer Address
    Smith & Nephew, Inc., 130 & 120 Forbes Blvd, Mansfield MA 02048
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA